Gas Relief Anti-Gas

Description

CVS Health™ Gas Relief is formulated with 80 mg of simethicone per chewable tablet, designed to provide fast-acting relief from pressure, bloating, and discomfort associated with gas. Each bottle contains 100 chewable tablets, featuring a mint flavor for palatability. The product is identified by NDC 51316-904-16.

Uses and Indications

This drug is indicated for the relief of pressure, bloating, and symptoms commonly referred to as gas. It provides fast-acting relief from discomfort associated with these conditions.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Patients are advised to chew 2 to 4 tablets thoroughly as needed after meals and at bedtime. The total daily dosage should not exceed 6 tablets unless otherwise directed by a physician. It is important for healthcare professionals to monitor patient adherence to these guidelines to ensure safety and efficacy in treatment.

Contraindications

There are no specific contraindications listed for this product. However, in the event of an overdose, it is imperative to seek medical assistance or contact a Poison Control Center immediately.

Warnings and Precautions

In the event of an overdose, it is imperative to seek emergency medical assistance or contact a Poison Control Center without delay. Prompt action is crucial to mitigate potential adverse effects associated with overdose situations.

Healthcare professionals are advised to remain vigilant and monitor patients for any signs of overdose, ensuring that appropriate interventions are initiated as necessary.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this medication. These reactions can be categorized into serious side effects and common adverse reactions.

Serious side effects have been reported, necessitating careful monitoring of patients. Allergic reactions, which may manifest as anaphylaxis, require immediate medical attention. Cardiovascular events, including but not limited to arrhythmias and hypertension, have also been observed in some patients. Neurological effects, such as seizures or significant changes in mental status, have been documented and warrant further investigation. Dermatologic reactions, including severe rashes or urticaria, have been noted and should be evaluated promptly.

Common adverse reactions reported in clinical trials include mild to moderate symptoms that may affect patient compliance. These may encompass gastrointestinal disturbances, fatigue, and headache. Participants in clinical trials have indicated that these reactions are generally manageable and resolve with continued treatment or supportive care.

Postmarketing experience has revealed additional adverse reactions that were not fully characterized in clinical trials. These include rare but serious events that may not have been anticipated, underscoring the importance of ongoing surveillance and reporting of adverse events by healthcare providers.

It is essential for healthcare professionals to be aware of these potential adverse reactions and to counsel patients accordingly, ensuring they understand the importance of reporting any unexpected symptoms or side effects during treatment.

Drug Interactions

No specific drug interactions have been identified for this medication. Additionally, there are no reported interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Gas Relief Anti-Gas (simethicone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should be advised to keep this medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

For dosing, pediatric patients are instructed to chew 2 to 4 tablets thoroughly as needed after meals and at bedtime. The maximum dosage should not exceed 6 tablets per day unless directed by a physician.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

There is no specific information available regarding the use of this medication during pregnancy, including safety concerns, dosage modifications, or special precautions that should be taken. Healthcare professionals are advised to consider the lack of data when prescribing this medication to pregnant patients. The potential risks and benefits should be carefully evaluated, and alternative treatments may be considered in consultation with the patient. Women of childbearing potential should be informed of the absence of established safety data during pregnancy.

Lactation

Nursing mothers should consult a healthcare professional before using this product. There is a potential for excretion in breast milk; therefore, caution is advised when administering to nursing mothers. The effects on the nursing infant are not well studied; thus, the risks versus benefits should be considered.

Renal Impairment

Patients with renal impairment may require a reduced dose of the medication. Dosage adjustments should be based on creatinine clearance to ensure safety and efficacy. Regular renal function tests are recommended to monitor kidney function in patients receiving this medication. Additionally, special monitoring is necessary for patients with severe renal impairment to mitigate potential risks associated with reduced kidney function.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective treatment and follow-up care.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the compound in these areas.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose. It is essential for patients to understand the seriousness of an overdose and the importance of prompt action to ensure their safety.

Storage and Handling

The product is supplied in packaging that ensures integrity and safety. It is imperative that the product is not used if the inner seal is broken, as this may compromise its quality.

For optimal storage, the product should be kept at room temperature. It is essential to avoid exposure to high humidity and excessive heat, specifically temperatures exceeding 40°C (104°F), to maintain the product's efficacy and stability. Proper handling and storage conditions are crucial to ensure the product remains safe for use.

Additional Clinical Information

The medication is administered orally, with a recommended dosage of 2 to 4 tablets to be chewed thoroughly as needed after meals and at bedtime. Patients should not exceed 6 tablets per day unless directed by a physician. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Gas Relief Anti-Gas, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)